Steba biotech gets USFDA Fast Track designation for Padeliporfin ImPACT to treat cancer
Luxembourg: Steba biotech has recently announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track designation for padeliporfin ImPACT for the treatment of adult patients with low-grade and unifocal high-grade Upper Tract Urothelial Cancer (UTUC).
This swiftly follows clearance of the Investigational New Drug (IND) application granted in December 2020 allowing initiation of the pivotal Phase 3 clinical trial of padeliporfin ImPACT in patients with low-grade UTUC, expected to begin enrollment in Q1 2021.
Steba biotech is focusing on the development of padeliporfin ImPACT as an innovative oncology platform with the potential to offer surgery-like efficacy, combined with organ preservation in UTUC and other solid tumors where the needs of the high-risk surgical patient are not being met – either because surgery is not the preferred clinical option (e.g. to delay the loss of a kidney) or the risk of surgery is too high.
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